跳至主要内容
临床试验/NCT02836444
NCT02836444已完成不适用

STratification AND Outcome of Patients With the Acute Respiratory Distress Syndrome - A Second Phase Study

Dr. Negrin University Hospital16 个研究点 分布在 1 个国家目标入组 422 人开始时间: 2015年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
422
试验地点
16
主要终点
variables associated with highest and lowest mortality

研究概览

简要总结

Current definitions of the Acute Respiratory Distress Syndrome (ARDS) could be adequate for epidemiological studies but are not adequate for inclusion of patients into therapeutic clinical trials. It is a matter of debate whether the assessment of hypoxemia at ARDS onset is appropriate for stratifying lung severity and risk of death in ARDS patients. The investigators will perform an observational, non-interventional, multicenter, prospective audit in a network of intensive care units in Spain for evaluating the severity and risk of death based on the assessment of respiratory and ventilatory function at 24 hours after ARDS diagnosis under standardized ventilatory conditions. This study is the confirmatory phase of the study NCT02288949.

详细描述

In 2012, an update of the ARDS definition (The Berlin criteria) was published and an empirical classification was proposed according to three PaO2/FiO2 cut-off values at ARDS onset: severe (≤100 mmHg), moderate (>100 - ≤200 mmHg), and mild (>200 - ≤300 mmHg) on positive end-expiratory pressure (PEEP) ≥5 cmH2O. However, despite that there is sufficient evidence about the interactions between PEEP and FiO2, these cut-off values did not mandate the assessment of hypoxemia under standardized guidelines.

The PaO2/FiO2 can be easily manipulated. Alterations in PEEP and FiO2 can dramatically change the PaO2/FiO2. Despite recent reports on the effects of standardized ventilator settings on PaO2/FiO2, is still a matter of debate whether the assessment of hypoxemia must be performed at 24 hours instead of at ARDS onset, and whether the assessment of hypoxemia under standardized ventilator settings is the most appropriate tool for stratifying lung severity in patients with ARDS.

The investigators will examine whether the values of relevant variables (including age, plateau pressure, driving pressure, compliance, PaO2/FiO2) at 24 after ARDS diagnosis under standardized ventilator settings have an impact on the stratification and prediction of death in ARDS patients. This study is an extension of the study NCT02288949.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients meeting the Berlin criteria for moderate and severe ARDS.

排除标准

  • 未提供

结局指标

主要结局

variables associated with highest and lowest mortality

时间窗: at 24 hours

variables associated with highest and lowest mortality

次要结局

  • stratification by risk of death(at 24 hours)

研究者

发起方
Dr. Negrin University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jesus Villar

Director, Multidisciplinary Organ Dysfunction Evaluation Research Network

Dr. Negrin University Hospital

研究点 (16)

Loading locations...

相似试验

Stratification of the Acute Respiratory Distress... | 临床试验